Cleared Special

K100888 - MODIFICATION TO LANX POSTERIOR CERVICOT...

K100888 is an FDA 510(k) clearance for MODIFICATION TO LANX POSTERIOR CERVICOT..., manufactured by Lanx, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Special 510(k) pathway after a 230-day FDA review.

K100888 · Lanx, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
230d
Days
Class 2
Risk

K100888 is an FDA 510(k) clearance for the MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Lanx, Inc. (Broomfield, US). The FDA issued a Cleared decision on November 15, 2010 after a review of 230 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Lanx, Inc. devices

FDA 510(k) Submission Details - K100888

510(k) Number K100888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2010
Decision Date November 15, 2010
Days to Decision 230 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 122d · This submission: 230d
Pathway characteristics
Modification to existing cleared device.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - KWP Appliance, Fixation, Spinal Interlaminal

All 309
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K100888.
SP-FIX SPINOUS PROCESS FIXATION PLATE
K102195 · Globus Medical, Inc. · Jan 2011
CASPIAN SPINAL SYSTEM
K103232 · K2m, Inc. · Jan 2011
AXLE INTERSPINOUS FUSION SYSTEM
K101471 · X-Spine Systems, Inc. · Nov 2010
MODIFICATION TO: OASYS SYSTEM
K101183 · Stryker Spine · Nov 2010
PIONEER SPINOUS PROCESS FUSION PLATE
K101525 · Pioneer Surgical Technology · Oct 2010
CASPIAN SPINAL SYSTEM
K101084 · K2m, Inc. · Oct 2010